Last month saw the EU executive secure 80 million doses of the vaccine, with the possibility to buy 80 million more, at a later stage, which it has done so now, bringing its mRNA-1273 order officially to 160 million doses in total.
A positive opinion from the scientific committee for human medicines (CHMP) of the European Medicines Agency (EMA) and the EU Commission decision regarding conditional marketing authorization (CMA) for the vaccine is still pending, of course.
The CHMP meeting is planned for January 6, 2021.
The first deliveries of mRNA-1273 to European countries from Modena’s dedicated European supply chain are expected to commence early in 2021 following EMA regulatory approval.
“We appreciate the confidence in Moderna and mRNA-1273, our COVID-19 vaccine candidate, demonstrated by today’s increased supply agreement with the European Commission,” said Stéphane Bancel, CEO, Moderna. “As we shift our focus now to prepare for the delivery of our vaccine candidate, pending a positive opinion from the EMA and other regulators, we remain committed to working with governments and partners globally to address this pandemic.”
Global supply agreements
Moderna has the following supply agreements, to date, with countries around the globe:
- US: 200 million doses with option for an additional 300 million doses
- EU: 160 million doses
- Japan: 50 million doses
- Canada: 40 million doses with option for an additional 16 million doses
- Switzerland: 7.5 million doses
- UK: 7 million doses
- Israel: 6 million doses
- Other countries, which have placed orders and have not been disclosed
Emergency use in the US
On Friday (December 18), the US Food and Drug Administration’ (FDA) authorized the emergency use of Moderna’s vaccine against COVID-19 in individuals 18 years of age or older.
Following, the announcement, Moderna said delivery to the US government would begin immediately.
The company said it would continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure for mRNA-1273 in 2021.
Moderna has also expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8°C (36° to 46°F).
“In some cases, this may be the only practical means of distribution from clinics and for remote locations. This important update will help facilitate distribution to the final site of administration,” said the company.
Moderna previously announced that mRNA-1273 remains stable at standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days.
The vaccination regime for mRNA-1273 involves two doses for each person, spaced one month apart.